EMBOGUARD BG8795URecalls & reported problems

Summary

The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 10886704082743), received between May 31, 2022 and Sep 30, 2026 — classified as 2 deaths, 33 injuries, 118 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (55 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 153 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955182 ↗
• MalfunctionSep 15, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782231 ↗
• MalfunctionSep 14, 2026Break

  A healthcare professional reported that during treatment to a cerebral aneurysm an EMBOGUARD 87, 95 CM Balloon Guide Catheter (product code: BG8795U, lot number: 10449662) was placed in the internal carotid artery, and upon inflation of the balloon, the balloon was found to have ruptured. The balloon was inflated to facilitate advancement of the EmboGuard distally, but due to the balloon rupture, the procedure was continued with the EmboGuard remaining at the internal carotid artery. The procedure was completed successfully without further issues. The devices were used according to the instructions for use (IFU). There was no negative impact to the patient. A continuous flush was done. The lesion was internal carotid artery. Other concomitant devices were Exselsior SL 10 microcatheter.Additional event information received on 28-Aug-2026 and 31-Aug-2026 confirmed that there was no allegation of patient injury due to an alleged product issue. No balloon fragments were observed. According to the physician, the balloon did not rupture due to overinflation; rather, it is possible that the balloon had developed a tear at some point, which prevented it from being inflated. Final angiograp

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752987 ↗
• MalfunctionJun 18, 2026Burst Container or Vessel

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, AN EMBOGUARD 87, 95 CM BALLOON GUIDE CATHETER (PRODUCT CODE: BG8795U, LOT NUMBER: 9301096) EXPERIENCED BALLOON INFLATION, IT COULD NOT WITHSTAND THE PRESSURE AND BURST. IT WAS NOTED THAT THE AMOUNT INJECTED WAS AS STATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25549751 ↗
• MalfunctionMay 26, 2026Material Separation; Device Damaged by Another Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A MECHANICAL THROMBECTOMY TO TREAT ACUTE ISCHEMIC STROKE. THE PROCEDURE WAS PERFORMED BY COMBINED TECHNIQUE USING REACT 71 CATHETER. THE PROCEDURE WAS PERFORMED AS USUAL. THE EMBOGUARD 87, 95 CM (PRODUCT CODE: BG8795U, LOT NUMBER: 10293947) WAS CONFIRMED TO BE COMPLETELY BROKEN. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. IT IS UNKNOWN IF A CONTINUOUS FLUSH DONE. THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280245 ↗
• MalfunctionMay 19, 2026Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY TO TREAT ACUTE ISCHEMIC STROKE (AIS), A 0.035 GUIDEWIRE, AN INNER CATHETER, AND AN EMBOGUARD 87, 95 CM (PRODUCT CODE: BG8795U, LOT NUMBER: 10293947) WERE ADVANCED TO THE COMMON CAROTID ARTERY. UPON REMOVAL OF THE INNER CATHETER, A KINK WAS OBSERVED ON THE EMBOGUARD, SO IT WAS REPLACED WITH A NEW BALLOON GUIDING CATHETER. THE PROCEDURE WAS COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. PUNCTURE SITE WAS THE GROIN. KINKING OCCURRED UPON REMOVAL OF THE INNER CATHETER. THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE EMBOGUARD WAS PREPARED ACCORDING TO IFU. ADDITIONAL EVENT INFORMATION RECEIVED ON 18-MAY-2026 INDICATED THAT THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218456 ↗
• MalfunctionMay 19, 2026Difficult to Advance; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE, THE DISTAL PART 5CM OF AN EMBOGUARD 87, 95 CM (PRODUCT CODE: BG8795U, LOT NUMBER: 9914821) WAS KINKED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 02-MAY-2026 INDICATED THAT THERE WAS NO DAMAGE TO THE PACKAGING. THERE WAS NO DIFFICULTY IN REMOVING DEVICE FROM PACKAGING. THE EVENT DID NOT RESULT IN ANY CONSEQUENCE OR INJURY TO THE PATIENT. THERE WAS NO BREAK IN DEVICE INTEGRITY AT THE SITE OF THE DEFECT. THE SURGICAL PROCEDURE WAS FROM THE FEMORAL ARTERY. A 8F INTRODUCER SHEATH WAS USED. THE DEVICE WAS NOT ABLE TO REACH THE TARGET POSITION. NO ASPIRATION WAS ATTEMPTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216757 ↗
• MalfunctionMay 13, 2026Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A MECHANICAL THROMBECTOMY OF THE MIDDLE CEREBRAL ARTERY, SEGMENT M1 TO TREAT ACUTE CEREBRAL INFARCTION. ATTEMPTED TO ADVANCE THE EMBOGUARD 87, 95 CM BALLOON CATHETER (PRODUCT CODE: BG8795U, LOT NUMBER: 10140061), BUT THE AORTA WAS LOOPED. AFTER ADVANCING TO THE COMMON CAROTID ARTERY, REMOVED THE INNER CATHETER, AT THAT TIME THE EMBOGUARD GOT KINKED. REPLACED THE EMBOGUARD WITH A NEW ONE AND ADVANCED AGAIN. THE NEW EMBOGUARD COULD BE ADVANCED WITHOUT ISSUE, AND RECANALIZATION WAS ACHIEVED BY ONE PASS USING A COMBINED TECHNIQUE (A CEREGLIDE 71 AND EMBOTRAP 5X37). THE PROCEDURE WAS COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICE WAS TRAK MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163025 ↗
• MalfunctionMay 6, 2026Difficult to Advance; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A MECHANICAL THROMBECTOMY TO TREAT AN ACUTE ISCHEMIC STROKE (AIS). DURING ADVANCEMENT OF THE EMBOGUARD 87, 95 CM (PRODUCT CODE: BG8795U, LOT NUMBER: 10293947) DID NOT ADVANCE FULLY TO THE INTERNAL CAROTID ARTERY (ICA) AND GOT KINKED WHEN THE INNER DEVICE WAS WITHDRAWN. AFTER THE EMBOGUARD REMOVAL, REPLACED WITH A NEW EMBOGUARD AND CHANGED THE METHOD OF ADVANCING. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER PROBLEMS. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS DONE. PUNCTURE SITE WAS THE GROIN. THE KINKING OCCURRED DURING REMOVAL OF THE INNER CATHETER. LOCATION OF CATHETER TIP: COMMON CAROTID ARTERY (CCA). THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). PERFORMED AIR REMOVAL ACCORDING TO IFU. ADDITIONAL EVENT INFORMATION RECEIVED ON 06-MAY-2026 INDICATED THAT THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096331 ↗
• MalfunctionMay 4, 2026Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT AN ACUTE ISCHEMIC STROKE (AIS), AN EMBOGUARD 87, 95 CM (PRODUCT CODE: BG8795U, LOT NUMBER: 10140061) WAS PREPARED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND USED AS A BALLOON GUIDE CATHETER. DURING USE, KINKING OCCURRED WHEN THE INNER DEVICE WAS WITHDRAWN, SO THE EMBOGUARD WAS REPLACED WITH ANOTHER NEW BALLOON GUIDE CATHETER (BGC) AND THE PROCEDURE WAS RESUMED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. LOCATION OF THE CATHETER TIP WAS THE COMMON CAROTID ARTERY (CCA). A CONTINUOUS FLUSH WAS DONE. ADDITIONAL EVENT INFORMATION RECEIVED ON 15-APR-2026 INDICATED THAT THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071017 ↗
• MalfunctionApr 28, 2026Difficult to Advance; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY, WHILE NAVIGATING AN EMBOGUARD 87, 95 CM BALLOON GUIDE CATHETER (PRODUCT CODE: BG8795U, LOT NUMBER: UNKNOWN) INTO POSITION, THE CATHETER DID NOT TRACK THROUGH THE ANATOMY AS EXPECTED. IN ADDITION, THE MID-SECTION OF THE CATHETER KINKED DURING THE PROCEDURE. THIS WAS CONFIRMED BY THE PHYSICIAN WHEN INSPECTING THE CATHETER AFTER THE OPERATION. THE TARGET DESTINATION FOR THE CATHETER WAS PETROUS INTERNAL CAROTID ARTERY (P-ICA) AND THE CATHETER KINKED WHILE TAKING THIS BEND. ADDITIONAL EVENT INFORMATION RECEIVED ON 28-APR-2026 INDICATED THAT THE TARGET VESSEL/SITE WAS THE MIDDLE CEREBRAL ARTERY (MCA). THERE WAS NO RELEVANT ANATOMICAL INFORMATION INCLUDING VESSEL CHARACTERISTICS. THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021059 ↗
• MalfunctionApr 21, 2026Fluid/Blood Leak; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THROMBECTOMY PROCEDURE TARGETING THE RIGHT INTERNAL CAROTID ARTERY (ICA) LARGE VESSEL OCCLUSION (LVO), THE 95CM EMBOGUARD 87 BALLOON GUIDE CATHETER (BGC) (BG8795U / 10060509) WAS USED WITH AN 80CM 8F ARROW SHEATH. THE PHYSICIAN REPORTED FEELING MORE FRICTION THAN USUAL INSERTING THE EMBOGUARD THROUGH THE ARROW SHEATH. THE SPLIT INTRODUCER WAS USED TO INSERT THE EMBOGUARD THROUGH THE HUB OF THE ARROW SHEATH, BUT THE PHYSICIAN REPORTED FRICTION THROUGHOUT THE INSERTION OF EMBOGUARD THROUGH THE ARROW SHEATH. DURING INFLATION OF THE EMBOGUARD BALLOON WITH THE LUER-ACTIVATED VALVE (LAV) AND 3CC SYRINGE, THE PHYSICIAN NOTICED THE BALLOON WAS NOT HOLDING INFLATION, EVEN WHEN REMOVING THE SYRINGE FROM THE LAV. THE PHYSICIAN THEN REINFLATED THE BALLOON AND NOTICED A SMALL LEAK ON THE ANGIOGRAM. THE EMBOGUARD BALLOON WAS KEPT DEFLATED AND THE THROMBECTOMY PROCEEDED TO SUCCESSFUL COMPLETION. THERE WERE NO PATIENT HARM AND NO SIGNIFICANT LOSS OF TIME. ON 14-APR-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, A PEEL-AWAY SHEATH WAS USED. A DILATOR WAS ALSO USED AND THEN IT WAS REPLACED WITH AN ACCESS CATHETER. THE EMBOGUARD BALLOO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945933 ↗
• MalfunctionApr 13, 2026Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY TO TREAT AN ACUTE ISCHEMIC STROKE (AIS). THE EMBOGUARD 87, 95 CM (PRODUCT CODE: BG8795U, LOT NUMBER: 0000263518) WAS USED AS A BALLOON GUIDING CATHETER (BGC). THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). AFTER PREPARATION, AN EMBOGUARD KINK OCCURRED DURING USE. THE EMBOGUARD WAS REPLACED WITH ANOTHER NEW BGC AND THE PROCEDURE WAS RESUMED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PUNCTURE SITE WAS AT THE GROIN. THE TIMING OF THE KINK WAS WHEN THE INNER DEVICE WAS BEING WITHDRAWN. THE LOCATION OF THE CATHETER TIP WAS AT THE COMMON CAROTID ARTERY (CCA). THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS PERFORMED. THE LESION WAS UNKNOWN. OTHER CONCOMITANT DEVICES WERE UNKNOWN. ADDITIONAL EVENT INFORMATION RECEIVED ON 09-APR-2026 INDICATED THAT THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24859558 ↗
• MalfunctionApr 9, 2026Failure to Advance; Material Twisted/Bent; Physical Resistance/Sticking

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A MECHANICAL THROMBECTOMY OF RIGHT INTERNAL CAROTID ARTERY VIA FEMORAL APPROACH TO TREAT ACUTE ISCHEMIC STROKE. THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE EMBOGUARD 87, 95 CM BALLOON GUIDE CATHETER (PRODUCT CODE: BG8795U, LOT NUMBER: 9948491) WAS ADVANCED OVER A 0.035-INCH GUIDEWIRE AND A DIAGNOSTIC CATHETER AND THE EMBOGUARD WAS PLACED IN THE RIGHT COMMON CAROTID ARTERY. AFTER PERFORMING ANGIOGRAPHY, ATTEMPTED TO ADVANCE THE ASPIRATION CATHETER, BUT IT COULD NOT ADVANCE WITHIN THE EMBOGUARD. UNDER FLUOROSCOPY, THE EMBOGUARD WAS FOUND TO BE KINKED AT THE ORIGIN OF THE COMMON CAROTID ARTERY. THEREFORE, THE EMBOGUARD WAS REMOVED AND REPLACED WITH A COMPETITOR¿S BALLOON CATHETER. THE PROCEDURE WAS COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS NOT DONE. THE LESION WAS RIGHT COMMON CAROTID ARTERY. OTHER CONCOMITANT DEVICE WAS TRAK MICROCATHETER, RADIFOCUS 0.035 INCH. ADDITIONAL EVENT INFORMATION RECEIVED ON 01-APR-2026 INDICATED THAT THERE WERE NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832337 ↗
• MalfunctionMar 17, 2026Burst Container or Vessel; Inflation Problem

  ON (B)(6) 2026, THE PATIENT UNDERWENT A MECHANICAL THROMBECTOMY AND CAROTID ARTERY STENTING OF THE RIGHT INTERNAL CAROTID ARTERY (ICA) TO AN OCCLUSION IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE DEVICES WERE USED IN ACCORDANCE WITH THEIR INSTRUCTIONS FOR USE (IFUS). THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, AFTER PREPARATION, THE 95 CM EMBOGUARD 87 BALLOON GUIDE CATHETER (BGC) (BG8795U / 10011658) WAS ADVANCED AND PLACED IN THE RIGHT ICA USING A 6 FR. 125 CM SIMMONS CATHETER AS A COAXIAL CATHETER. AN ATTEMPT WAS MADE TO INFLATE THE EMBOGUARD BALLOON CATHETER; HOWEVER, THE EMBOGUARD BALLOON FAILED TO EXPAND, AND A BALLOON RUPTURE WAS SUSPECTED. THE EMBOGUARD WAS REMOVED FROM THE PATIENT¿S BODY AND REPLACED WITH A NEW EMBOGUARD BALLOON, WHICH WAS SIMILARLY ADVANCED AND PLACED. THE THROMBECTOMY WAS THEN PERFORMED VIA THE COMBINED TECHNIQUE USING A 6.5 MM X 45 MM EMBOTRAP III REVASCULARIZATION DEVICE AND A RED 62 REPERFUSION CATHETER. THE CAROTID ARTERY STENTING WAS PERFORMED FOR THE RESIDUAL STENOSIS, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPAC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621107 ↗
• MalfunctionMar 5, 2026Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY, AN EMBOGUARD 87, 95 CM BALLON GUIDE CATHETER (PRODUCT CODE: BG8795U, LOT NUMBER: UNKNOWN) WAS KINKED AT MID BODY, THEREFORE ASPIRATION CATHETER COULD NOT ENTER INSIDE. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-FEB-2026 INDICATED THAT THE KINK OCCURRED INSIDE THE PATIENT, PRIOR TO ASPIRATION OR DELIVERING STENT RETRIEVER. THE EMBOGUARD WAS REMOVED AND REPLACED WITH AN OPTIMO BALLON GUIDE CATHETER. IT WAS NOTED THAT THE EVENT RESULTED IN ANY UNDUE PROCEDURAL DELAY, HOWEVER, THERE WAS NO PATIENT HARM. THERE WAS NO DAMAGE TO THE PACKAGING. THERE WAS SO DIFFICULTY IN REMOVING DEVICE FROM PACKAGING. THERE WAS NO BREAK IN MATERIAL INTEGRITY AT THE SITE OF THE DEFECT, SUCH AS CRACKING OR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518621 ↗
• MalfunctionMar 3, 2026Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WITH SEVERE HARDENING OF THE ARTERIES UNDERWENT A MECHANICAL THROMBECTOMY PROCEDURE TO REMOVE A BLOOD CLOT FROM THE LEFT INTERNAL CAROTID ARTERY, THE MAIN VESSEL SUPPLYING BLOOD TO THE BRAIN. AN EMBOGUARD 87, 95 CM BALLOON GUIDE CATHETER (PRODUCT CODE: BG8795U, LOT NUMBER: 9968236) ALONG WITH A TRAK MICROCATHETER (MC) WERE USED ACCORDING TO THE INSTRUCTIONS FOR SUE (IFU). THE EMBOGUARD WAS SUCCESSFULLY GUIDED INTO THE ARTERY. HOWEVER, DURING REMOVAL, A KINK OCCURRED IN THE INNER DEVICE. THE EMBOGUARD WAS PULLED TO THE COMMON CAROTID ARTERY, AND THE THROMBECTOMY WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. THE PROCEDURE WAS FOR AN ACUTE ISCHEMIC STROKE (AIS), AORTA ARCH TYPE: 1, PUNCTURE SITE AT THE GROIN. LOCATION OF CATHETER TIP: KINK OCCURRED DURING THE EMBOGUARD PLACEMENT IN THE INTERNAL CAROTID ARTERY. IT WAS PULLED INTO THE COMMON CAROTID ARTERY AND THE TREATMENT WAS CONTINUED. ADDITIONAL EVENT INFORMATION RECEIVED ON 02-MAR-2026 INDICATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. NO ADDITIONAL INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496764 ↗
• MalfunctionFeb 26, 2026Fluid/Blood Leak; Material Twisted/Bent; Material Split, Cut or Torn

  ON (B)(6) 2026, DURING A MECHANICAL THROMBECTOMY PROCEDURE TARGETING THE LEFT MIDDLE CEREBRAL ARTERY (MCA) TO TREAT AN ACUTE ISCHEMIC STROKE, DEVICES WERE USED IN ACCORDANCE WITH THEIR RESPECTIVE INSTRUCTIONS FOR USE (IFUS). ACCESS WAS VIA RIGHT FEMORAL ARTERY. THE 95 CM EMBOGUARD 87 BALLOON GUIDE CATHETER (BGC) (BG8795U/10060520) WAS USED VIA APPROACH FROM RIGHT GROIN PUNCTURE. THERE WAS SEVERE VESSEL TORTUOSITY OBSERVED, ¿AND THE ANGLE AT THE ORIGIN OF THE LEFT COMMON CAROTID ARTERY WAS QUITE STEEP, MAKING DELIVERY DIFFICULT. NEVERTHELESS, THE EMBOGUARD COULD BE DELIVERED TO THE ORIGIN OF THE LEFT INTERNAL CAROTID ARTERY. AFTER THAT, ANGIOGRAPHY SHOWED A KINK (SEPARATED PART) AND CONTRAST LEAKAGE, SO THE EMBOGUARD WAS REMOVED FROM THE PATIENT¿S BODY. [A] KINK WAS CONFIRMED ON THE EMBOGUARD OUTSIDE THE PATIENT¿S BODY. THE EMBOGUARD WAS REPLACED WITH A BRANCHOR FROM [ASAHI-INTECC] AND THE PROCEDURE WAS CONTINUED. RECANALIZATION WAS ACHIEVED SUCCESSFULLY, AND THE PROCEDURE WAS COMPLETED.¿ CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. THE PHYSICIAN COMMENTED THAT ¿ACCESS WAS DIFFICULT DURING THE PROCEDURE AND TORQUE WAS APPLIED TO THE EMBOGUARD, WHICH MAY HAVE CONTRIBUTED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456563 ↗
• MalfunctionFeb 18, 2026Difficult to Advance; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE TARGETING AN OCCLUSION IN THE MIDDLE CEREBRAL ARTERY (MCA) TO TREAT AN ACUTE ISCHEMIC STROKE (AIS), DEVICES WERE USED IN ACCORDANCE WITH THEIR INSTRUCTIONS FOR USE (IFUS). ACCESS WAS VIA THE FEMORAL ARTERY. THE 8 FR INTRODUCER (TERUMO), A RADIFOCUS® GUIDEWIRE (TERUMO) AND THE 95CM EMBOGUARD 87 BALLOON GUIDE CATHETER (BGC) (BG8795U / 9888409) WERE INSERTED, DURING WHICH RESISTANCE WAS FELT. THE TREVO TRAK ® 21 MICROCATHETER (STRYKER) AND SYNCHRO SELECT GUIDEWIRE (STRYKER) WERE LOADED INTO THE EMBOGUARD AND DELIVERED INTO THE VESSEL, ¿AT WHICH POINT, STRONG RESISTANCE WAS FELT WITHIN THE EMBOGUARD.¿ CONTINUOUS FLUSH WAS MAINTAINED. THE PROCEDURE CONTINUED; THE THROMBUS WAS RETRIEVED USING THE CEREGLIDE 57 CATHETER AND THE TIGERTRIEVER17 DEVICE (RAPID MEDICAL). THE PROCEDURE WAS SUCCESSFULLY COMPLETED. UPON REMOVING THE EMBOGUARD FROM THE PATIENT¿S ANATOMY, IT WAS FOUND TO BE KINKED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 12-FEB-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE REPORTED KINK WAS FOUND AFTER THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378792 ↗
• MalfunctionFeb 13, 2026Product Quality Problem; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE TARGETING AN OCCLUSION IN THE COMMON CAROTID ARTERY (CCA), A COMBINATION OF A ¿HALF STIFF WIRE AND A JB2 CATHETER WAS ADVANCED INTO THE AORTA. BECAUSE THE VESSEL WAS MARKEDLY TORTUOUS, THE INNER CATHETER WAS KEPT POSITIONED IN THE AORTA ON STANDBY WHILE THE WIRE WAS ADVANCED FIRST.¿ THE 95CM EMBOGUARD 87 BALLOON GUIDE CATHETER (BGC) (BG8795U / 8943735) WAS THEN ADVANCED ALONG THE WIRE FROM THE AORTIC ARCH TO THE CCA, ¿HOWEVER, ANGIOGRAPHIC IMAGE WAS SOMEWHAT POOR AND THE EMBOGUARD WAS CONFIRMED TO BE KINKED PARTIALLY. THEN THE CEREGLIDE WAS ADVANCED WITHOUT ISSUES AND USED AFTERWARDS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.¿ CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 12-FEB-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT A JB2 CATHETER WAS ALSO USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24338017 ↗
• MalfunctionFeb 4, 2026Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT A MECHANICAL THROMBECTOMY WAS BEING PERFORMED TO TREAT AN ARTERIAL EMBOLISM. THE EMBOGUARD BALLOON CATHETER (PRODUCT CODE BG8795U, LOT 10060507) WAS PREPARED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). DURING THE PROCEDURE, INTERNAL CAROTID ARTERY STENOSIS WAS PRESENT, WHICH CAUSED THE EMBOGUARD CATHETER TO BE UNSTABLE. WHILE CAROTID ARTERY STENTING WAS BEING PERFORMED, THE EMBOGUARD WAS POSITIONED AT A LOW LOCATION. UPON REMOVAL OF THE INNER DEVICE, THE EMBOGUARD WAS OBSERVED TO BE KINKED. THE DEVICE WAS REMOVED AND REPLACED WITH AN OPTIMO 9F BALLOON CATHETER, AFTER WHICH THE PROCEDURE WAS RESUMED AND SUCCESSFULLY COMPLETED. A CONTINUOUS FLUSH WAS MAINTAINED THROUGHOUT THE PROCEDURE. NO PATIENT INJURY OR NEGATIVE CLINICAL IMPACT WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 03 FEB 2026 CONFIRMED THAT THERE WAS NO ALLEGATION OF PATIENT INJURY RELATED TO THE REPORTED PRODUCT EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259789 ↗
• MalfunctionJan 29, 2026Material Twisted/Bent; Physical Resistance/Sticking

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A MECHANICAL THROMBECTOMY OF THE LEFT MIDDLE CEREBRAL ARTERY, SEGMENT M2 OCCLUSION TO TREAT ACUTE CEREBRAL INFARCTION USING ONLY AN ASPIRATION CATHETER. ATTEMPTED TO INSERT A 132CM CEREGLIDE 71 CATHETER (PRODUCT CODE: NIC71132C, LOT NUMBER: UNKNOWN) INTO AN EMBOGUARD 87, 95 CM BALLOON CATHETER (PRODUCT CODE: BG8795U, LOT NUMBER: 9914822), BUT THERE WAS RESISTANCE ON THE INITIAL ATTEMPT. AFTER THE CEREGLIDE 71 WAS REPLACED WITH CATALYST6 (NO RESISTANCE ON INSERTION), THE THROMBECTOMY WAS PERFORMED. RECANALIZATION WAS NOT ACHIEVED, BUT THE PROCEDURE WAS COMPLETED. THE PATIENT'S CONDITION REMAINED UNCHANGED BEFORE TRANSFERRING TO THE HOSPITAL. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICES WERE EMBOGURAD 95CM GUIDING CATHETER, CHIKAI NEXUS GUIDEWIRE, TRAK MICROCATHETER. THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). VERIFICATION WAS PERFORMED WITH THE DEVICES ACTUALLY USED, AND STRONG RESISTANCE WAS CONFIRMED DURING THE CEREGLIDE INSERTION (STRONG RESISTANCE WAS FELT WHEN ADVANCING FROM THE HUB TO THE ORANGE PORTION). ALSO, SEVERAL KINKS WERE OBSERVED NEAR THE DIST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24210512 ↗
• MalfunctionJan 26, 2026Inflation Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, TARGETING THE INTERNAL CAROTID ARTERY (ICA) TO TREAT AN ACUTE ISCHEMIC STROKE (AIS), DEVICES WERE USED IN ACCORDANCE WITH THEIR RESPECTIVE INSTRUCTIONS FOR USE (IFUS). WHEN THE 95CM EMBOGUARD 87 BALLOON GUIDE CATHETER (BGC) (BG8795U / 10011658) WAS ADVANCED TO THE VERTEBRAL ARTERY, THE PHYSICIAN ATTEMPTED TO FURTHER ADVANCE IT USING ¿A FLOATING TECHNIQUE¿ BUT THE BALLOON CATHETER NEVER INFLATED. THE EMBOGUARD WAS REPLACED WITH ANOTHER PRODUCT FROM ANOTHER MANUFACTURER, AND THE PROCEDURE WAS SUCCESSFULLY COMPETED WITH THE REPLACEMENT DEVICE. IT WAS REPORTED THAT THE DEVICE PREPARATION ¿WAS DONE IN WET, AND THE BALLOON INFLATION WAS NOT ATTEMPTED AT THAT TIME.¿ CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS COMPLAINT FILE WILL BE UPDATED ACCORDINGLY. BASED ON THE PRODUCT INVESTIGATION COMPLETED ON 23-JAN-2026, THE ISSUE REPORTED HAS BEEN DETERMINED TO BE REPORTABLE AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179684 ↗
• MalfunctionJan 9, 2026Fracture; Product Quality Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY, THE MARKER BAND OF AN EMBOGUARD 87, 95 CM BALLOON GUIDE CATHETER (PRODUCT CODE BG8795U, LOT NUMBER: 9968236) APPEARED ABNORMAL, BEING DIFFICULT TO VISUALIZE AND BENT AT A 90-DEGREE ANGLE DURING INSERTION. AS A PRECAUTION, THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NON J&J PRODUCT, ALLOWING THE PROCEDURE TO BE COMPLETED SUCCESSFULLY. THERE WAS NO NEGATIVE IMPACT OR CONSEQUENCE TO THE PATIENT, AND NO SIGNS, SYMPTOMS, OR PATIENT INVOLVEMENT WERE OBSERVED. THE DEVICE WAS NOT IMPLANTED AND IS AVAILABLE FOR RETURN. ADDITIONAL EVENT INFORMATION RECEIVED ON 06-JAN-2026 INDICATED THAT NO VISIBLE DAMAGE/SEPARATION WAS OBSERVED. THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020907 ↗
• MalfunctionJan 5, 2026Burst Container or Vessel; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TREATING A CEREBRAL INFARCTION WITH THE OCCLUSION IN THE INTERNAL CAROTID ARTERY (ICA), THE DEVICES WERE USED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFUS). THE 95CM EMBOGUARD 87 BALLOON GUIDE CATHETER (BGC) (BG8795U / 9968236) WAS USED FOR THE SUBARACHNOID HEMORRHAGE (SAH), AND IT RUPTURED DURING USE. IT WAS REPORTED THAT THE EMBOGUARD BGC WAS REPLACED WITH A NEW DEVICE AND THE PROCEDURE CONTINUED. A CONTINUOUS FLUSH WAS MAINTAINED; THE CONCOMITANT MICROCATHETER WAS A PHENOM¿ MICROCATHETER (MEDTRONIC). THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ADDITIONAL INFORMATION IS PENDING. ADDITIONAL INFORMATION WAS RECEIVED ON 23-DEC-2025. PER THE INFORMATION, ¿THE VESSEL WAS SEVERELY CALCIFIED AND TORTUOUS, AND THE EMBOGUARD WAS BEING ADVANCED WITH THE BALLOON INFLATED. THE PHYSICIAN COMMENTED THAT THE BALLOON LIKELY CONTACTED A CALCIFIED LESION AT SOME POINT AND RUPTURED, MAKING INFLATION IMPOSSIBLE. KINK WAS OBSERVED ON THE RETRIEVED EMBOGUARD CATHETER, BUT THERE WERE NO COMMENTS ABOUT CATHETER DAMAGE SUCH AS KINK DURING ADVANCEMENT. IT IS POSSIBLE THE CATHETER KINKED DURING REMOVAL FROM THE PATIENT¿S BODY.¿ ON 29-DEC-2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23961396 ↗